Mintz Levin - Health Law & Policy Matters

701 Pennsylvania Avenue, N.W.
Washington, DC 20004-2608, United States

  • 202-434-7324
  • 202-434-7400

D.C. Circuit Upholds Contraceptive Coverage Mandate

Last week, a unanimous three-judge panel of the D.C. Circuit upheld the religious accommodation to the Affordable Care Act’s (“ACA”) contraceptive coverage mandate (Priests for Life v. HHS, D.C. Cir. No. 13-5368, Nov. 14, 2014)…more
| Civil Procedure, Commercial Law & Contracts, Constitutional Law, Labor & Employment Law, Health

Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices

Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food and…more
| Civil Remedies, Criminal Law, Health, Science, Computers, & Technology, Government Contracting

The Seventh Circuit Rejects Medicaid False Claims Act Suit

The United States Court of Appeals for the Seventh Circuit affirmed the dismissal of a False Claims Act (“FCA”) case against Shopko Operating Stores, LLC, in which a former Shopko pharmacist asserted Medicaid billing violations…more
| Civil Procedure, Labor & Employment Law, Health, Science, Computers, & Technology, Government Contracting

The 340B Mega-Reg is Dead

With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.” And to…more
| Administrative Law, Health, Science, Computers, & Technology

Health Care Update - November 2014 #2

In This Issue: - Smoother Open Enrollment Sets Stage for Shift in Congressional Focus - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Congressional…more
| Elections & Politics, Health, Insurance

OCR’s New Bulletin on Ensuring Privacy in Public Health Emergencies

This week, the HHS Office of Civil Rights (OCR) issued a bulletin (Bulletin) to remind covered entities and business associates that “the protections of the Privacy Rule are not set aside during an emergency.” The…more
| Consumer Protection, Privacy, Health

Special Edition Health Care Update - Elections Wrap Up, Lame Duck Preview, and a Changing Congress

In This Issue: - Impact of Midterm Elections - Lame Duck Preview - Ebola Epidemic and Lame Duck Response - Implementation of the Affordable Care Act - Other Federal Regulatory…more
| Elections & Politics, Health, Insurance

CMS Finalizes OPPS Rule Packaging Pathology Services Ordered for Hospital Outpatients

As part of the Outpatient Prospective Payment System (OPPS) Rule issued last week, the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to conditionally package certain ancillary services assigned to APCs…more
| Health

Health Care Update - November 2014

In This Issue: - CMS Releases Final Medicare Payment Rules - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional Initiatives - Other Health…more
| Elections & Politics, Health

Key Takeaways from OIG’s 2015 Work Plan

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to HHS…more
| Health, Science, Computers, & Technology

CME Payments Largely Remain Excluded From Sunshine Act Reporting

The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). When CMS proposed several…more
| Health, Science, Computers, & Technology

CMS Announces Plan for Reporting Returned Sunshine Act Payment Data

On October 30, 2014, the Centers for Medicare and Medicaid Services (“CMS”) announced the procedure for applicable manufacturers and group purchasing organizations (“GPOs”) to report payment and ownership information that was…more
| Privacy, Health, Science, Computers, & Technology

The Contraception Coverage Controversy Continues…

As we have been discussing, the Affordable Care Act (“ACA”) requires all health plans to cover preventive health services for women, including all Food and Drug Administration (“FDA”)-approved contraceptives, at no cost (i.e. no…more
| Civil Procedure, Civil Remedies, Constitutional Law, Labor & Employment Law, Health

Ebola Update–CDC Issues New Protocols

The response to Ebola continues to evolve as additional resources for providers and the public have been made available over the last several days. The Joint Commission (TJC) launched an Ebola Preparedness Resources webpage,…more
| Labor & Employment Law, Health

Office for Human Research Protections Releases Draft Guidance

On October 24, 2014, the Office for Human Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research…more
| Health, Science, Computers, & Technology
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Areas of Practice
  • Administrative Law
  • Commercial Law & Contracts
  • Health
  • Litigation
  • Mergers & Acquisitions
  • Securities Law
Locations
Other U.S. Locations
  • California
  • Connecticut
  • D.C.
  • Massachusetts
  • New York
Other Countries
  • Israel
  • United Kingdom
Number of Attorneys

25-50 Attorneys

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